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    Maintenance treatment with rucaparib for recurrent ovarian carcinoma in ARIEL3, a randomized phase 3 trial: The effects of best response to last platinum-based regimen and disease at baseline on efficacy and safety

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    Authors
    Oaknin, A.
    Oza, A. M.
    Lorusso, D.
    Aghajanian, C.
    Dean, A.
    Colombo, N.
    Weberpals, J. I.
    Clamp, Andrew R
    Scambia, G.
    Leary, A.
    Holloway, R. W.
    Amenedo Gancedo, M.
    Fong, P. C.
    Goh, J. C.
    O'Malley, D. M.
    Armstrong, D. K.
    Banerjee, S.
    Garcia-Donas, J
    Swisher, E. M.
    Cameron, T.
    Maloney, L.
    Goble, S.
    Ledermann, J. A.
    Coleman, R. L.
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    Affiliation
    Gynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain
    Issue Date
    2021
    
    Metadata
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    Abstract
    Background: The efficacy and safety of rucaparib maintenance treatment in ARIEL3 were evaluated in subgroups based on best response to most recent platinum-based chemotherapy and baseline disease. Methods: Patients were randomized 2:1 to receive either oral rucaparib at a dosage of 600 mg twice daily or placebo. Investigator-assessed PFS was assessed in prespecified, nested cohorts: BRCA-mutated, homologous recombination deficient (HRD; BRCA mutated or wild-type BRCA/high loss of heterozygosity), and the intent-to-treat (ITT) population. Results: Median PFS for patients in the ITT population with a complete response to most recent platinum-based chemotherapy was 11.1 months in the rucaparib arm (126 patients) versus 5.6 months in the placebo arm (64 patients) (HR, 0.33 [95% CI, 0.23-0.48]), and in patients with a partial response (249 vs. 125), it was 9.0 versus 5.3 months (HR, 0.38 [0.30-0.49]). In subgroups of the ITT population based on baseline disease, median PFS was 8.2 versus 5.3 months (HR, 0.40 [0.28-0.57]) in patients with measurable disease (141 rucaparib vs. 66 placebo), 10.4 versus 4.5 months (HR, 0.31 [0.20-0.48]) in those with nonmeasurable but evaluable disease (104 vs. 56), and 14.1 versus 7.3 months (HR, 0.35 [0.24-0.51]) in those with no residual disease (130 vs. 67). Across subgroups, significantly longer median PFS was observed with rucaparib versus placebo in the BRCA-mutated and HRD cohorts. Objective responses were reported in patients with measurable disease and in patients with nonmeasurable but evaluable baseline disease. Safety was consistent across subgroups. Conclusion: Rucaparib maintenance treatment provided clinically meaningful efficacy benefits across subgroups based on response to last platinum-based chemotherapy or baseline disease.
    Citation
    Oaknin A, Oza AM, Lorusso D, Aghajanian C, Dean A, Colombo N, et al. Maintenance treatment with rucaparib for recurrent ovarian carcinoma in ARIEL3, a randomized phase 3 trial: The effects of best response to last platinum?based regimen and disease at baseline on efficacy and safety. Vol. 10, Cancer Medicine. Wiley; 2021. p. 7162�73.
    Journal
    Cancer Medicine
    URI
    http://hdl.handle.net/10541/624666
    DOI
    10.1002/cam4.4260
    PubMed ID
    34549539
    Additional Links
    https://dx.doi.org/10.1002/cam4.4260
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1002/cam4.4260
    Scopus Count
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